Blood control IV catheter with antimicrobial properties

ABSTRACT

A system and method is provided for applying an anti-pathogenic material to various surfaces of a medical device, wherein the method includes identifying various surfaces of the medical tests which include noncritical dimensions, and limiting the application of the anti-pathogenic material to those surfaces. Some aspects of the invention further include the application of an anti-pathogenic lubricant material to various parts or components of a medical device to reduce friction.

BACKGROUND OF THE INVENTION

The current invention relates to systems and methods for coating varioussurfaces of medical devices with an anti-pathogenic material. Inparticular, the present invention relates to systems and methods foridentifying surfaces within a medical device which include noncriticaldimensions, wherein an anti-pathogenic material is applied to theseidentified surfaces to reduce or eliminate pathogenic colonization andgrowth within the medical device.

A formidable challenge of modern medical treatment is control ofinfection in the spread of pathogenic organisms. One area where thischallenge is constantly presented is in infusion therapy of varioustypes. Infusion therapy is one of the most common healthcare procedures.Hospitalized, home care, and other patients receive fluids,pharmaceuticals, and blood products via a vascular access deviceinserted into the vascular system of the patient. Infusion therapy maybe used to treat an infection, provide anesthesia or analgesia, providenutritional support, treat cancerous growths, maintain blood pressureand heart rhythm, or many other clinically significant uses.

Infusion therapy is facilitated by a vascular access device. Thevascular access device may access the patient's peripheral or centralvasculature. The vascular access device may be indwelling for short-term(days), moderate term (weeks), or long-term (months two years). Thevascular access device may be used for continuous infusion therapy orfor intermittent therapy.

A common vascular access device comprises a plastic catheter insertedinto a patient's vein. The catheter length may vary from a fewcentimeters or peripheral access, to many centimeters for central accessand may include devices such as peripherally inserted central catheters(PICC). The catheter may be inserted transcutaneously or may besurgically implanted beneath the patient's skin. The catheter, or anyother vascular access device attached thereto, may have a single lumenor multiple lumens for infusion of many fluids simultaneously.

A vascular access device may serve as a nidus, resulting in adisseminated BSI (blood stream infection). This may be caused by failureto regularly flush the device, a non-sterile insertion technique, or bypathogens that enter the fluid flow path through either end of the pathsubsequent to catheter insertion. When a vascular access device iscontaminated, pathogens adhere to the vascular access device, colonize,and form a biofilm. The biofilm is resistant to most biocidal agents andprovides a replenishing source of pathogens to enter a patient'sbloodstream and cause a BSI.

One approach to preventing biofilm formation and patient infection is toprovide an anti-pathogenic coating on various medical devices andcomponents. However, some medical devices and components comprisematerials or features which are incompatible with anti-pathogeniccoatings. Thus, although methods exist for providing an anti-pathogeniccoating on various medical devices and components, challenges stillexist. Accordingly, it would be an improvement in the art to augment oreven replace current techniques with other techniques. Such techniquesare disclosed herein.

BRIEF SUMMARY OF THE INVENTION

In order to overcome the limitations discussed above, the presentinvention relates to systems and methods for selectively coatingnon-dimensionally critical surfaces of medical devices which contactblood or other fluids as part of an infusion therapy.

Some implementations of the present invention include an infusiontherapy medical device having a surface which includes a noncriticaldimension, wherein an anti-pathogenic material is applied to thesurface. In some instances, the surface further comprises a portion of afluid pathway through the device. Thus, the anti-pathogenic material isexposed to a fluid flowing through the fluid pathway of the device.

In some instances, an infusion therapy medical device is provided havinga septum actuator which includes a probe portion configured to advancethrough a septum of the device upon actuation of the septum actuator. Insome implementations, an anti-pathogenic material including a lubricantagent is applied to the probe portion of the septum actuator to reducefriction between the septum actuator and the septum during activation ofthe device. In other implementations, a rigid or semirigidanti-pathogenic material is applied to various surfaces of a baseportion of the septum actuator.

Certain aspects of the present invention further include a color codesystem, whereby the identity of the anti-pathogenic material isidentified based upon the color of the medical device.

Some aspects of the present invention include a medical device having acompatible surface which includes at least one mechanical bond wherebyto facilitate binding between the surface and an anti-pathogenicmaterial. Other aspects of the invention include providing a chemicalbond between a compatible surface of a medical device and ananti-pathogenic material by surface cross-linking.

The present invention further includes various methods, techniques, andmaterials for identifying and coating surfaces of medical devices whichinclude noncritical dimensions. Thus, an anti-pathogenic material may beapplied to various surfaces within a medical device to reduce oreliminate pathogenic colonization and/or growth within the medicaldevice thereby reducing the risk of pathogenic infection in patients.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a cross-section view of a catheter assembly comprising aseptum actuator prior to activation, the catheter assembly and septumactuator having various surfaces with critical and noncriticaldimensions in accordance with a representative embodiment of the presentinvention.

FIG. 2 is a cross-section view of the catheter assembly comprising aseptum actuator following activation in accordance with a representativeembodiment of the present invention.

FIG. 3 is a detailed, cross-section view of a catheter assemblycomprising a septum actuator following activation in accordance with arepresentative embodiment of the present invention.

FIG. 4 is a cross-section view of a catheter assembly followingactivation via a Luer adapter in accordance with a representativeembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiment of the present invention will be bestunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

The term “proximal” is used to denote a portion of a device which,during normal use, is nearest the user and furthest from the patient.The term “distal” is used to denote a portion of a device which, duringnormal use, is farthest away from the user wielding the device andclosest to the patient. The term “activation” of valve mechanism orseptum is used to denote the action of opening or closing of such valve.For example, in some embodiments a catheter assembly is provided havinga septum and a septum actuator, wherein the catheter assembly undergoesactivation when the septum actuator is advanced through the septum,thereby providing a fluid pathway through the septum.

The term “critical dimension” is used to denote at least one of aheight, a length, a width, a depth, a diameter, a thickness, an angle, atexture, or other structural feature of a surface of a medical devicewhich is critical to the operation of the device. For example, in someembodiments a medical device may include a surface that is configured tointerface with another device or component. As such, the surface mayinclude a critical dimension that is configured to accommodate optimalinteraction between the surface of the medical device and theinterfacing device or component. Thus, in some embodiments a surfacehaving a critical dimension must remain unmodified to preserve theintended and/or desired interaction of the surface in operating or usingthe medical device. Conversely, the term “noncritical dimension” is usedto denote at least one of a height, a length, a width, a depth, adiameter, a thickness, an angle, a texture, or other structural featureof a medical device with is not critical to the operation of the device.

The terms “chemical bond” or “chemical bonding” are used to denote anattraction between atoms that allows an anti-pathogenic material to beapplied to a desired surface of a medical device. For example, in someinstances an anti-pathogenic material of the present invention isapplied to the surface of an infusion therapy medical device viachemical bonding, wherein atoms of the anti-pathogenic material andatoms of the medical device are chemically attracted to one another.Chemical bonding may include any type of atomic bond, such as a covalentbond, an ionic bond, dipole-dipole interactions, London dispersionforce, Van der Waals force, and hydrogen bonding. A chemical bond mayfurther be denoted by the terms “cross-linking” or “surfacecross-linking” for some embodiments.

The terms “mechanical bond” or “mechanical bonding” are used to denote aphysical, non-chemical interaction between two or more materials. Forexample, in some instances a surface of a medical device is altered toinclude a texture, a groove and/or a ridge having a void which holds ananti-pathogenic material via capillary force. In other embodiments, amechanical bond comprises a structural feature which provides increasedsurface area to a surface of a medical device. Further, in someembodiments a mechanical bond comprises a hydrophilic or hydrophobicmaterial or coating that is applied to a surface of a medical device toattract an anti-pathogenic material. A mechanical bond may further bedenoted by the term “mechanical interlock” for some embodiments.

The term “compatible surface” is used to denote a surface of a medicaldevice which includes a noncritical dimension, or a surface whichincludes a critical dimension that will not be adversely affected by theaddition of an anti-pathogenic material or coating.

The terms “rigid” or “semirigid” are used to denote a physical propertyof an anti-pathogenic material, wherein the material is deficient in, ordevoid, or mostly devoid of flexibility. Alternatively, these terms areused to denote an inflexible or mostly inflexible physical property ofan anti-pathogenic material when applied or coated onto a surface of adevice. In some instances, the term semirigid is understood to describea physical property of an anti-pathogenic material that is rigid to somedegree or in some parts.

The term “modified rheology” is used to denote a physical property of ananti-pathogenic material, wherein the viscosity of an anti-pathogenicmaterial is modified to prevent excessive migration of theanti-pathogenic material once applied to a surface of a device. As such,the modified rheology of the anti-pathogenic material prevents orsubstantially prevents contact between the anti-pathogenic material andadjacent surfaces or components.

The term “anti-pathogenic” is used to denote a material, such as acoating material, that acts against pathogens. Pathogens may include anyorganism or substance capable of causing a disease, such as bacteria,viruses, protozoa and fungi. Accordingly, an “anti-pathogenic material”as contemplated herein includes any material having properties foracting against a pathogen.

The present invention relates generally to systems and methods forapplying anti-pathogenic materials to various surfaces of medicaldevices. In particular, the present invention relates to systems andmethods for applying anti-pathogenic materials to surfaces of medicaldevices for infusion therapies, wherein the surface comprises a portionof a fluid pathway of the medical device. In some instances, ananti-pathogenic material is applied to a surface comprising anoncritical dimension. In some embodiments, an anti-pathogenic materialis applied to one or more surfaces of a medical device prior toassembling the medical device. In other embodiments, an anti-pathogenicmaterial is applied to first portion or component of a medical deviceand subsequently transferred to a second portion or component of themedical device through controlled migration of the anti-pathogenicmaterial. In other instances, an anti-pathogenic material is intermixedwith, or incorporated into the material of the medical device during amolding process of the device. Further, in some instances ananti-pathogenic material is applied to or incorporated into the materialof a medical device such that the anti-pathogenic material elutes outfrom the material of the medical device into the immediate surroundingsof the coated medical device.

In general, an anti-pathogenic material in accordance with the presentinvention may include any material having anti-pathogenic propertieswhich may be applied to the surface of a medical device. For example, insome embodiments an anti-pathogenic material may include anantimicrobial composition, as taught in U.S. patent application Ser.Nos. 12/397,760, 11/829,010, 12/476,997, 12/490,235, and 12/831,880,each of which is incorporated herein by reference, in its entirety. Insome embodiments, an anti-pathogenic material may further include ananti-infective or antimicrobial lubricant, as taught in U.S. patentapplication Ser. Nos. 12/436,404 and 12/561,863, each of which isincorporated herein in its entirety. Further, in some embodiments ananti-pathogenic material is incorporated into the material of a medicaldevice, or a component thereof, such as a septum actuator.

Some embodiments of the present invention comprise a medical device orcomponent having at least one surface that defines a portion of a fluidpathway through the medical device. The surface of the medical device iscoated with an anti-pathogenic material to prevent colonization ofpathogens on the coated surface.

The application of an anti-pathogenic material to the surface of amedical device results in the addition of a layer or “coat” ofanti-pathogenic material to the surface. This layer of anti-pathogenicmaterial has a dimension (i.e. thickness) which may affect arelationship between the coated surface and an interfacing or adjacentcomponent of the medical device. For example, in some embodiments amedical device may include an aperture having a diameter to compatiblyreceive a second medical device, such as by a friction, press,mechanical or interference fit. As such, the diameter of the apertureincludes critical dimensions to ensure proper fitting between theaperture and the second medical device. In this example, the addition ofan anti-pathogenic material to the surface of the aperture will adjustthe diameter of the aperture thereby adversely affecting the ability ofthe aperture to receive the second medical device.

Accordingly, in some embodiments of the present invention it isundesirable to modify or coat a surface of a medical device or componentwherein the surface includes a critical dimension that will be adverselyaffected by the addition of the anti-pathogenic material. Thus, someembodiments of the present invention comprise a method for coating amedical device with an anti-pathogenic material, wherein the methodincludes a first step of identifying surfaces of the medical devicewhich include noncritical dimensions. The method may further include astep whereby the surfaces having noncritical dimensions are then coatedwith an anti-pathogenic material. Some methods of the present inventionmay further include steps for identify and isolating surfaces of themedical device having critical dimensions, prior to coating theremaining surfaces with an anti-pathogenic material.

In further example of the teachings of the present invention, a catheterassembly device 10 is shown in FIGS. 1-4. Catheter assembly device 10provides a non-limiting example of a medical device having varioussurfaces which may be coated with an anti-pathogenic material.Accordingly, catheter assembly device 10 provides a representativeembodiment on which to demonstrate and discuss the methodologies of thepresent invention relating to the selection and coating of surfaces withan anti-pathogenic material.

Referring now to FIG. 1, a cross-section view of a catheter assembly 10is shown. Catheter assembly 10 generally includes a catheter 12 coupledto a distal end 22 of a catheter adapter 20. Catheter 12 and catheteradapter 20 are integrally coupled such that can internal lumen 26 ofcatheter adapter 20 is in fluid communication with a lumen 14 ofcatheter 12. Catheter 12 generally comprises a biocompatible materialhaving sufficient rigidity twisting pressures associated with insertionof the catheter into a patient. In some embodiments, catheter 12comprises a metallic material, such as titanium, stainless steel,nickel, molybdenum, surgical steel, and alloys thereof. In otherembodiments, catheter 12 comprises a rigid, polymer material, such asvinyl or silicon.

Catheter assembly 10 may further include features for use with anover-the-needle catheter assembly. For example, a flexible or semiflexible polymer catheter may be used in combination with a rigidintroducer needle to enable insertion of the catheter into thevasculature of a patient. Surgically implanted catheters may also beused.

Once inserted into a patient, catheter 12 and catheter adapter 14provide a fluid conduit to facilitate delivery of a fluid to and/orretrieval of a fluid from a patient, as required by a desired infusionprocedure. Thus, in some embodiments the material of the catheter 12 andthe catheter adapter 14 are selected to be compatible with bio-fluidsand medicaments commonly used in infusion procedures. Additionally, insome embodiments a portion of the catheter 12 and/or catheter adapter 14is configured for use in conjunction with a section of intravenoustubing (not shown) to further facilitate delivery of a fluid to orremoval of a fluid from a patient.

The various embodiments of the present invention may be adapted for usewith any medical device or accessory having a lumen in which is seated aseptum. For example, in some embodiments a female Luer adapter coupledto a section of intravenous tubing may comprise a septum and a septumactuator in accordance with the present teachings. In other embodiments,one or more ends of a y-port adapter may comprise a septum and a septumactuator in accordance with the teachings of the present invention.

In some embodiments, a proximal end 24 of the catheter adapter 14includes a flange 28. Flange 28 provides a positive surface which may beconfigured to enable coupling of intravenous tubing or a Luer adapter tothe catheter assembly 10. In some embodiments, flange 28 furtherincludes a set of threads to accept a Luer adapter via a threadedconnection.

In some embodiments, an inner surface of catheter adapter 20 comprises agroove or channel 16 in which is seated a septum 40. Septum 40 generallycomprises a flexible, or semi-flexible polymer plug having an outerdiameter that is configured to compatibly seat within channel 16. Insome embodiments, septum 40 is barrel shaped having a barrier surface 42comprising a distal end of the septum 40 and further having an opening44 comprising a proximal end of the septum 40. When positioned withinchannel 16, barrier surface 42 divides inner lumen 26 into a proximalfluid chamber 30 and a distal fluid chamber 32. Thus, the presence ofseptum 40 controls or limits passage of fluid between the proximal anddistal fluid chambers 30 and 32.

In some embodiments, catheter assembly 10 further comprises a septumactuator 50. Septum actuator 50 is generally positioned within proximalfluid chamber 30 at a position adjacent septum 40. In some instances,septum actuator 50 comprises a base 52 which is positioned adjacent to aproximal opening 44 of catheter adapter 20. Septum actuator 50 furthercomprises a probe 54 which is positioned adjacent barrier surface 42 ofseptum 40 prior to activation of catheter assembly 10.

In some embodiments, septum actuator 50 is slidably housed withincatheter adapter 20, such that septum actuator 50 comprises anindependent component of catheter assembly 10. Septum actuator 50 may becoated with an anti-pathogenic material prior to being inserted intocatheter adapter 20. In some instances, septum actuator 50 is coatedwith a rigid or semirigid anti-pathogenic material such that fluid whichbypasses septum actuator 50 comes in contact with the anti-pathogenicmaterial. In other instances, septum actuator 50 is coated with aviscous or fluid anti-pathogenic material such that the anti-pathogenicmaterial is transferred to surfaces of catheter assembly 10 which comein contact with the anti-pathogenic material. Further still, in someinstances the material of septum actuator 50 comprises ananti-pathogenic material or agent. For example, the material of septumactuator 50 may include an anti-pathogenic material which isincorporated into or admixed with the material of septum actuator 50during a molding process. In some instances, the anti-pathogenicmaterial is capable of eluding out of septum actuator 50 into thesurrounding areas within the catheter adapter 20. For example, a fluidpassing through catheter adapter 20 may be treated with theanti-pathogenic material of septum actuator 50 by either directlycontacting the anti-pathogenic material or by contacting anti-pathogenicmaterial which has eluded from the material of septum actuator 50.

In some embodiments, a septum actuator 50 is provided within a fluidpathway of catheter assembly 10, such that all fluid passing throughcatheter assembly 10 come in contact with septum actuator 50, or pass inproximity to septum actuator 50 through immediate surroundings of septumactuator 50. Thus, some embodiments of the present invention provideanti-pathogenic treatment of a fluid within catheter assembly 10 byproviding a septum actuator 50 having an external or exposed surfacewhich is coated with anti-pathogenic material. Further, some embodimentsof the present invention prevent bacterial colonization within a fluidpathway of catheter assembly 10 by providing a septum actuator 50 havingan anti-pathogenic coating material coated thereon. In some instances,an anti-pathogenic material is applied to various surfaces of septumactuator 50 which comprise noncritical dimensions. In other instances,an anti-pathogenic material is applied to various surfaces of septumactuator 50 which comprise critical and noncritical dimensions. Furtherstill, in some instances an anti-pathogenic material is applied to allsurfaces of septum actuator 50 which may come in contact with a fluidflowing through a fluid pathway of catheter assembly 10.

Septum actuator 50 may comprises various features to facilitate use ofseptum actuator 50 within catheter assembly 10. For example, septumactuator 50 may include various vents and other structural features tocontrol fluid flow through and around septum actuator 50, as taught inU.S. patent application Ser. Nos. 12/703,336 and 12/703,406, each ofwhich is incorporated herein by reference, in its entirety. Septumactuator 50 may further include structural features to maintain theposition of septum actuator 50 within lumen 26 of catheter adapter 20.For example, in some embodiments septum actuator 50 comprises fins 56which are seated in channel 18 of catheter adapter 20. Channel 18restricts proximal and distal movement of septum actuator 50 betweenproximal and distal stops 36 and 38, respectively. Accordingly, prior toactivation fins 56 are positioned proximally within channel 18, adjacentproximal stop 36. Upon activation, septum actuator 50 is advanceddistally within channel 18 until fins 56 contact distal stop 38.

As discussed previously, various surfaces of catheter assembly 10comprise critical dimensions which may be adversely affected by theaddition of an anti-pathogenic coating or material. For example, channelor groove 16 comprises an inner diameter having a critical dimensionconfigured to receive septum 40. Accordingly, in some embodiments it isundesirable to apply an anti-pathogenic material to the surface ofgroove 16. Similarly, in some embodiments it is undesirable to apply ananti-pathogenic material to the outer surface of septum 40, wherein thediameter of the outer surface of septum 40 comprises a criticaldimension configured to form an interface with groove 16.

Further, channel 18 comprises a width, depth and length configured tocompatibly and slidably receive fins 56 of septum actuator 50.Accordingly, these dimensions of channel 18 comprise critical dimensionswhich may be undesirably affected by the addition of an anti-pathogenicmaterial. Thus, in some embodiments it is undesirable to apply ananti-pathogenic material to the surfaces of channel 18. Similarly, insome embodiments it is undesirable to apply an anti-pathogenic materialto the tips or interfacing surfaces of fins 56, wherein the tips orinterfacing surfaces of fins 56 comprise a critical dimension configuredto compatibly seat and slide within channel 18.

Catheter assembly 10 further comprises various surfaces which may becoated with an anti-pathogenic material, wherein the surfaces includenoncritical dimensions. For example, in some embodiments the innersurface of the distal fluid chamber 32 comprises a noncritical dimensionand is therefore coated with an anti-pathogenic material 60. Similarly,various surfaces of base 52 of septum actuator 50 comprise noncriticaldimensions and are therefore coated with anti-pathogenic material 60.Certain surfaces of proximal fluid chamber 30 further includenoncritical dimensions and may therefore be coated with anti-pathogenicmaterial 60. In particular, surfaces positioned between proximal stop 36and opening 44 of catheter adapter 20 comprise noncritical dimensions.

In general, anti-pathogenic material may be applied to any internal orexternal surface of a medical device, or a component of a medicaldevice, wherein the surface comprises or is exposed to a fluid pathwaythrough the medical device. The surface may further include a criticalor non-critical dimension. Pathogens within a fluid passing through themedical device are thus prevented from colonizing within the medicaldevice. In some embodiments, the thickness of the anti-pathogenicmaterial is proportionate to a duration of effectiveness of theanti-pathogenic material on the coated surface. Thus, the duration ofeffectiveness of the coating may be increased by increasing thethickness of the anti-pathogenic material applied to the surface. Theduration of effectiveness may further be modified through modifying thephysical properties of the anti-pathogenic material to increase ordecrease the rate at which the anti-pathogenic agents are capable ofeluting out of the coating material.

In some embodiments, a rigid or semirigid anti-pathogenic material 60 isselected which is configured to permit long-term elution of theanti-pathogenic agents contained within the material 60. As such, it isdesirable to provide the anti-pathogenic material to much of the fluidpath surface area of catheter assembly 10. In other embodiments, aviscous, fluid anti-pathogenic material 62 is selected which furthercomprises a lubricant agent. For example, in some embodiments ananti-pathogenic material 62 is provided which further includes a siliconlubricant agent, such as MED-460 (manufactured by NuSil Technology,LLC). The inclusion of a lubricious agent reduces friction betweeninterfacing components of catheter assembly 10. For example,anti-pathogenic material 62 is applied to the probe portion 54 of septumactuator 50, thereby reducing friction between septum actuator 50 andseptum 40. In some embodiments, anti-pathogenic material 62 furtherprovides a fluid-tight seal between septum 40 and the outer surface ofprobe 54. Further, in some embodiments anti-pathogenic material 62provides a fluid-tight seal to slit 46 of septum 40 prior to activationor provides a fluid-tight seal to slit 46 following removal of probe 54from septum 40.

Anti-pathogenic material 62 may be applied to portions of probe 54 priorto assembling catheter assembly 10. In some embodiments, anti-pathogenicmaterial 62 is capable of flowing or migrating when brought into contactwith other surfaces. Accordingly, in some embodiments excessanti-pathogenic material 62 from probe 54 is applied to septum 40following assembly of catheter assembly 10, as shown. In otherembodiments, anti-pathogenic material 62 comprises a modified rheologyto prevent or control excessive migration of anti-pathogenic material 62within catheter adapter 20. For example, anti-pathogenic material 62 mayfurther include rheological modifiers to increase the viscosity of thematerial, such as silica, talc or clay.

The process for coating or applying the anti-pathogenic material tocompatible surfaces of catheter assembly 10 may be accomplished bydipping the desired portions or components of the device in theirrespective coating material 60 and/or 62. Alternatively, anti-pathogenicmaterials may be sprayed onto the desired surfaces. In some embodiments,surfaces having critical dimensions are masked or otherwise protectedprior to applying the anti-pathogenic material to the remainingsurfaces. Compatible surfaces may further include a mechanical featureto encourage mechanical binding between the coating material and thecompatible surface.

For example, a compatible surface may be designed to include a physicalfeature that increases mechanical binding of the coating material, suchas a texture, a groove, a ridge or some other feature which increasesthe surface area of the compatible surface. In some embodiments, amechanical bond is facilitated by a mechanical interlock comprising avoid which holds the anti-pathogenic material by capillary force orsurface tension forces. In other embodiments, a mechanical interlockcomprises a hydrophilic or hydrophobic material or coating that isapplied to the compatible surface to attract the anti-pathogenicmaterial.

Further, in some embodiments the anti-pathogenic material is chemicallybound to the compatible surface of the catheter assembly or medicaldevice by a chemical bond, such as surface cross-linking. For example,in some embodiments a compatible surface of a device comprises a polymermaterial that is capable of forming chemical bonds with at least onecomponent of an anti-pathogenic material. Non-limiting examples ofpolymer materials which may be used to achieve surface cross-linkinginclude polycarbonate, polyester, and polyurethane. In some instances,an anti-pathogenic material is applied to a compatible surface of adevice and then cured to achieve surface cross-linking between theanti-pathogenic material and the surface of the device.

Referring now to FIG. 2, catheter assembly 10 is shown followingactivation with a Luer adapter 70. Catheter assembly 10 is activated asseptum actuator 50 is advanced distally thereby causing probe 54 toadvance through slit 46 of septum 40. In some embodiments, septumactuator 50 is advanced distally as Luer adapter 70 is inserted intoopening 44 of catheter adapter 20. In some embodiment, opening 44comprises a diameter and inner wall surface angle that is configured toreceive probe 72 of Luer adapter 70 in a friction or interference fit.Accordingly, in some embodiments it is undesirable to apply ananti-pathogenic material to opening 44, wherein an anti-pathogeniccoating would adversely affect the fit of probe 72 within opening 44.

Alternatively, in some embodiments opening 44 may be coated with ananti-pathogenic material that is viscous, yet fluid enough to bedisplaced by probe 72 upon coupling of Luer adapter 70 to proximal end24. In these embodiments, the anti-pathogenic material may act assealant between probe 72 and opening 44, wherein probe 72 removes thenecessary excess amount of anti-pathogenic material to leave a smallamount of anti-pathogenic material between the interfacing surface ofopening 44 and probe 72.

In some embodiments, an anti-pathogenic material 62 is configured totransfer to interfacing surface within the catheter assembly 10following activation. For example, in some embodiments anti-pathogenicmaterial on probe 54 of septum actuator 50 is transferred to septum 50and the septum slit 46 as probe 54 is advanced through slit 46. Further,anti-pathogenic material 60 on base 52 of septum actuator 50 istransferred to channel 18 as septum actuator 50 is advanced distallywithin catheter adapter 20. Thus, anti-pathogenic material 60 may beapplied to various surfaces of catheter assembly 10 in anticipation offurther distribution of the anti-pathogenic material followingactivation of the catheter assembly 10. In other embodiments,anti-pathogenic material 60 comprises a rigid or semirigid material thatis not transferred during activation of catheter assembly 10. A detailedview of catheter assembly 10 following activation is shown in FIG. 3.

In some embodiments, various other structural features and/or surfacesof catheter assembly 10 may include critical dimensions on which it isundesirable to apply an anti-pathogenic material. For example, in someinfusion therapy techniques it is desirable to permit a controlled flowof fluid through the septum 40 prior to activating the septum 40 withthe septum activator 50. Thus, in some embodiments slit 46 may furthercomprise a leak orifice having an opening diameter calculated to permitcontrolled flow of liquid or air between the proximal and distal fluidchambers 30 and 32. As this leak orifice includes critical dimensions,it would be undesirable to block or reduce the calculated openingdiameter by the addition of an anti-pathogenic material. Further, grooveor channel 16 may be modified to include air channels to permit passageof air between proximal and distal fluid chambers 30 and 32. These toowould include critical dimensions that would be adversely affected bythe addition of an anti-pathogenic material.

Referring now to FIG. 4, a catheter assembly 80 is shown followingactivation via a Luer adapter 70. In some embodiments, a catheterassembly 80 is provided which includes a septum 40 that is positionedproximate to opening 44, such that septum 40 may be actuated directly bya probe portion 72 of Luer adapter 70. As discussed previously, varioussurfaces of catheter assembly 80 are coated with an anti-pathogenicmaterial 60 and/or 62. Surfaces and portions of catheter assembly andLuer adapter 70 which are determined to include critical dimensions arenot coated with the anti-pathogenic material. However, in someembodiments an anti-pathogenic material 60 is applied to the fluidpathway 74 of Luer adapter 70, wherein it is determined that thedimensions of fluid pathway 74 comprise noncritical dimensions. Lueradapter 70 may further comprise a female Luer adapter, or a male Lueradapter.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

The invention claimed is:
 1. An infusion therapy medical device,comprising: a catheter adapter from which a catheter extends distally,the catheter adapter including a lumen, the lumen including a channelformed between a proximal stop and a distal stop; a septum positionedwithin the lumen distal to the distal stop, the septum dividing thelumen into a distal fluid chamber and a proximal fluid chamber; anintroducer needle that extends through the lumen of the catheter adapterand through the catheter to allow the catheter to be inserted into apatient's vasculature, the introducer needle being configured to beremoved from the lumen after insertion of the catheter; and a septumactuator disposed within the proximal fluid chamber, the septum actuatorcomprising a body with a lumen and a plurality of fins that extendradially outward from the body, the septum actuator being configured tomove from a proximal position in which the fins contact the proximalstop to a distal position in which the fins contact the distal stop, andwherein, when in the distal position, a distal end of the septumactuator extends through the septum, the septum actuator including arigid or semi-rigid anti-pathogenic material that is applied to aportion of the body but that is not applied to tips of the fins.
 2. Thedevice of claim 1, wherein the portion of the body to which the rigid orsemi-rigid anti-pathogenic material is applied comprises an externalsurface.
 3. The device of claim 1, wherein the portion of the body towhich the rigid or semi-rigid anti-pathogenic material is appliedcomprises an internal surface.
 4. The device of claim 1, wherein thedevice is selected from the group consisting of a catheter adapter and aLuer adapter.
 5. The device of claim 1, further comprising: a viscous orfluid anti-pathogenic material applied to a portion of the body of theseptum actuator.
 6. The device of claim 1, further comprising: a viscousor fluid anti-pathogenic material applied to a portion of the septum. 7.The device of claim 1, wherein the rigid or semi-rigid anti-pathogenicmaterial is applied to a portion of the lumen of the infusion therapymedical device but not to the channel.
 8. The device of claim 7, whereinthe portion of the lumen of the infusion therapy medical device includesa portion distal to the septum.
 9. The device of claim 1, furthercomprising an identifying color to indicate a specific type of theanti-pathogenic material.
 10. The device of claim 1, wherein the rigidor semi-rigid anti-pathogenic material is applied to the portion of thebody at a desired thickness that is proportionate to a duration ofeffectiveness of the anti-pathogenic material on the portion of thebody.